MISOBEST - Orally Misoprostol Solution (Cytotec®) Versus Orally Misoprostol as a Tablet (Angusta®) for Induction of Labor

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to evaluate efficacy of the cervical ripening of misoprostol administration in oral tablet, Angusta® compared with the off-label solution of misoprostol (Cytotec®) for induction of labor (IOL). Since there is a large cost difference between the preparations (Angusta® is 43 times more expensive than Cytotec®) it is, from a socio-economic perspective, of great interest to evaluate if Angusta can be replaced by Cytotec.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Singleton gestations

• Cephalic presentation

• ≥37-42+0 weeks of gestation

• Unfavorable cervix score BS <6 in nulliparous women and <5 in parous women

• All participating women in the studies will receive oral and written information and must give informed consent before participation

Exclusion Criteria:

1. Inability to understand the study information written in Swedish or English

2. Previous hysterotomy (scar in the uterine myometrium)

3. Non-reassuring cardiotocography (CTG) on admission (the door-test, first 20 minutes of registration of CTG).

4. Hypersensitivity to the active substance

5. If active labor has started

6. When oxytocin infusion is already used

7. Placenta previa

8. Renal failure (GFR <15 ml/min/1.73 m2).

9. Any condition or circumstance due to which the investigator considers it is not in the best interest of subject to participate in the study or the inclusion of a subject risks negatively impacting the scientific or ethical integrity of the clinical trial.